A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate as participants, and sign an informed consent form (ICF) before any procedures begin
The subject must have locally advanced or metastatic gastric cancer or gastroesophageal junction cancer that cannot be surgically removed, and the histopathological examination confirms it to be simple adenocarcinoma
Permissible Previous Treatment: Participants with gastric cancer or gastroesophageal junction cancer who have previously received adjuvant or neoadjuvant treatment and have experienced clinical disease progression at least 6 months after the last administration are eligible for inclusion. (Note: The treatment-related toxicity of oxaliplatin in previous adjuvant or neoadjuvant treatments must be restored to the National Cancer Institute [NCI] General Terminology Standard for Adverse Events [CTCAE] v5.0 Level 1 before enrollment)
CLDN18.2 positivity: Provide sufficient tissue markers for Claudin18.2 immunohistochemistry testing. Claudin18.2 immunohistochemistry expression ≥ 10% is confirmed as positive, and<10% is recorded as negative
Known HER2 positive gastric cancer/adenocarcinoma of the gastroesophageal junction. HER2 positivity refers to HER2 amplification that requires confirmation from ISH if the HER2 immunohistochemistry test result is 3+and the immunohistochemistry test result is 2+
Has undergone major surgery or radiation therapy within 4 weeks prior to enrollment;
Active, known or suspected autoimmune diseases
Congestive heart failure or symptomatic coronary artery disease within 3 months prior to enrollment
Single group
LM-302+Candonilimab+Capecitabine
DrugLM-302: 1.8mg/kg ivgtt d1, q2w; Canonilimab: 6mg/kg ivgtt d1, q2w; Capecitabine: 1000mg/m\^2 po bid d1-10, q2w.
Dose limiting toxicity (DLT)
DLT is defined as a toxicity (adverse event at least possibly related to LM302) occurring during the DLT observation period
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Overall Survival (OS)
OS was defined defined as the time from date of randomization until death from any cause.
Objective response rate (ORR)
defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Duration of response (DoR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Disease control rate (DCR)
defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
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